Pharmaceutical Executive Daily: FDA’s Agentic AI Deployment

Pharmaceutical Executive Daily: FDA’s Agentic AI Deployment


Welcome to Pharmaceutical Executive Daily, your quick briefing on the top news shaping the pharmaceutical and life sciences industry.

In today’s Pharmaceutical Executive Daily, Regeneron launches a $150 million gene editing collaboration with Tessera Therapeutics, the FDA begins agency-wide deployment of new agentic AI tools, and a new report suggests Richard Pazdur is stepping down as director of CDER.

Regeneron has announced a $150 million strategic collaboration with Tessera Therapeutics, focused on advancing next-generation gene editing technologies. The partnership aims to accelerate programmable genomic medicine platforms, combining Regeneron’s development capabilities with Tessera’s RNA-based gene writing tools.

The FDA has begun agency-wide implementation of agentic AI tools, an initiative intended to streamline workflow, enhance regulatory efficiency, and support more rapid analysis of complex datasets. According to the agency, the deployment will strengthen review consistency, modernize internal operations, and better position the FDA for emerging technologies.

Meanwhile, a new report indicates that Richard Pazdur is departing his role as director of the FDA’s Center for Drug Evaluation and Research (CDER). Pazdur has overseen numerous regulatory innovations during his tenure, and the reported leadership change could signal significant transition for the agency’s drug evaluation framework.

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